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YY/T 1629.6-2021Cutting tools for electric osseous tissue surgical equipment - Part 6: Rasp (English PDF)

电动骨组织手术设备刀具 第6部分:锉刀

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 1629.6-2021 is the English-translated version of 电动骨组织手术设备刀具 第6部分:锉刀.

YY/T 1629.6-2021 is the Chinese pharmaceutical industry standard for the rasps used as cutting tools on electric bone tissue surgery equipment, the files driven in reciprocating motion to shape bone.

It gives the terms and definitions, the construction types and the materials, then the requirements and the test methods, covering the geometry and the cutting teeth of the working part, the shank and its fit to the handpiece, the hardness and the corrosion resistance, the cutting performance and the heat produced, together with the instructions for use and the marking. Issued on 6 September 2021, it has applied since 1 September 2022.

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Document preview — YY/T 1629.6-2021

National Standard of the People's Republic of China

Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions YY/T 0752 and the following

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document is part 6 of YY/T 1629 "Electric Bone Tissue Surgery Equipment and Knives". YY/T 1629 has issued the following parts.

--- Part 1: Grinding head;

--- Part 2: Skull drill bits;

--- Part 4: Milling cutters;

--- Part 5: Saw blades;

--- Part 6: Files.

Introduction

YY/T 1629 "Electric Bone Tissue Surgery Equipment and Knives" series of product standards is divided into six parts, which is a Supplement to Tissue Surgical Equipment.

YY/T 1629 consists of six parts.

--- Part 1: Grinding head. The purpose is to standardize the safety and performance requirements of the grinding head in the electric bone tissue surgery equipment.

--- Part 2: Skull drill bits. The purpose is to standardize the safety and performance of the skull drill in the matching tool for electric bone tissue surgery equipment Require.

--- Part 3: Drill bits. The purpose is to standardize the safety and performance requirements of drill bits in electric bone tissue surgery equipment.

--- Part 4: Milling cutters. The purpose is to standardize the safety and performance requirements of milling cutters in electric bone tissue surgery equipment.

--- Part 5: Saw blades. The purpose is to standardize the safety and performance requirements of saw blades in electric bone tissue surgery equipment.

--- Part 6: Files. The purpose is to standardize the safety and performance requirements of the files in the electric bone tissue surgery equipment. Electric bone tissue surgery equipment knife Part 6: Files

1 Scope

This document specifies the terms and definitions, construction types, materials, requirements, test methods, instructions for electric bone tissue surgical equipment knife files book and logotype.

This document applies to rasps (hereinafter referred to as rasps) that are powered by electric bone tissue surgical equipment to perform reciprocating motion and file bone tissue. product).

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 1184 shape and position tolerances do not note tolerance values

GB/T 1220 stainless steel rod

GB/T 4340.1 Vickers Hardness Test for Metal Materials Part 1: Test Methods

GB/T 6682 Analysis Laboratory Water Specifications and Test Methods

GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods

YY/T 0752 Electric bone tissue surgery equipment "Pharmacopoeia of the People's Republic of China"

3 Terms and Definitions YY/T 0752 and the following

terms and definitions apply to this document. For ease of use, YY/T 0752 is repeated below Some terms and definitions in.

3.1 Rasp

It is a tool that is powered by electric bone tissue surgery equipment to perform reciprocating motion to file bone tissue.

Note. The file is usually composed of the file pattern, the file body, the connecting rod, the interface and other structural parts.

3.2 Mobile phone handpiece

A component held by an operator and capable of driving the held surgical tool for surgical purposes.

Note. The mobile phone can be one-piece or split, and the split type consists of a (power) handle that can provide power to the handpiece, a handpiece that clamps the tool, and (or) a variable speed and direction change mechanism, etc. component composition.

3.3 Raspcuts

The structural part that acts as a filing on the working surface of the product.

Note. The filing pattern is divided into main pattern and auxiliary pattern. The main pattern plays the main role of filing, and the auxiliary pattern plays the auxiliary role of filing.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

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